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The purpose of this study is to evaluate the efficacy and safety of ECP (PEG 3350) Colon Prep Kit compared with MoviPrep split-dose as a colon-cleansing preparation for colonoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECP Colon Prep Kit | Experimental |
| |
| MoviPrep® | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECP Colon Prep Kit | Drug | ECP Colon Prep Kit |
| |
| MoviPrep® |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with successful bowel cleansing defined as centrally read 4 point modified Aronchick Scale (1=Inadequate, 2=Fair, 3=Good, 4=Excellent) score of either good or excellent. | 24-hour period, beginning the day prior to the procedure and through the morning of the colonoscopy procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sue Hall | Sebela Pharmaceuticals Development LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sebela Site 007 | Anaheim | California | 92801 | United States | ||
| Sebela Site 006 |
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| ID | Term |
|---|---|
| C520497 | MoviPrep |
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| Drug |
MoviPrep® |
|
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Sebela Site 002 | Bastrop | Louisiana | 71220 | United States |
| Sebela Site 003 | Annapolis | Maryland | 21401 | United States |
| Sebela Site 004 | Great Neck | New York | 11023 | United States |
| Sebela Site 008 | Wilmington | North Carolina | 28403 | United States |
| Sebela Site 001 | Mentor | Ohio | 44060 | United States |
| Sebela Site 005 | Ogden | Utah | 84405 | United States |